Class I Medical Device Recall: Draeger Medical Fabius Series Anesthesia Machines

By Effective Medicine  On  In Medical Devices Tagged  

Recall Class:  Class I

Date Recall Initiated:  August 14, 2013

Products:

  • Fabius GS Premium Anesthesia Machines
  • Fabius OS Anesthesia Machines
  • Fabius Tiro Anesthesia Machines
  • Fabius Tiro D-M Anesthesia Machines

To locate product codes and lot numbers of affected products, refer to FDA’s Class I Recall.

The affected products were manufactured from February 1, 2013 to May 1, 2013 and distributed from March 1, 2013 to June 1, 2013.

Use:  The Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, and Fabius Tiro D-M anesthesia machines are used to administer anesthesia and ventilation to patients during surgical procedures.

Recalling Firm:
Draeger Medical, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969

Reason for Recall:
The minimum specified clearance between an electrical component and the unit housing was not maintained for some devices.  As a result, bypass current flowing in the interior of the unit may cause the automatic ventilation function of the device to fail.

The failure of this device may cause serious adverse health consequences, including death or injury caused by device failure to ventilate.

Public Contact: For questions about this recall, contact Draeger Medical Customer Service at 1-800-543-5047 Monday through Friday, 8 AM through 8 PM Eastern Standard Time.

FDA District:  Philadelphia District Office

FDA Comments:  
In August 2013, Draeger Medical sent an “Urgent Medical Device Recall” letter informing affected customers of the product, problem, and actions to be taken.  Customers were instructed to notify personnel of the problem and use the manual ventilation mode in the event of automatic ventilation failure.  The letter also directed customers that a representative from Draeger Medical would be contacting them to schedule a replacement of the power supply.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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